Clinical Trial: Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia.

PURPOSE: Randomizedphase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.

Condition Treatment or Intervention Phase
adult solid tumor
Anemia
Leukemia
Lymphoma
plasma cell neoplasm
 Drug: darbepoetin alfa
 Drug: epoetin alfa
 Procedure: complications of therapy assessment/management
 Procedure: hematologic toxicity attenuation
 Procedure: supportive care/therapy
Phase III

MedlinePlus related topics:  Anemia;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Darbepoetin alfa Versus Epoetin alfa for Anemia in Patients With Non-Myeloid Malignancies Receiving Chemotherapy

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Compare the safety of these drugs in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).
  • Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks. Patients are followed at 1 and 3 weeks .

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a non-myeloid malignancy
  • The following diagnoses are excluded:
  • Acute myeloid leukemia
  • Chronic myeloid leukemia
  • Acute lymphoblastic leukemia
  • Hairy cell leukemia
  • Burkitt's lymphoma
  • Lymphoblastic lymphoma
  • Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
  • Hemoglobin no greater than 11.0 g/dL
  • No other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin less than 2 times upper limit of normal (ULN)

Renal

  • Creatinine less than 2 times ULN

Cardiovascular

  • No angina
  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No hypertension
  • No cardiac arrhythmia
  • No other unstable or uncontrolled disease or condition that would affect cardiac function

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No known seizure disorder
  • No known sensitivity to study agents
  • No clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
  • No confirmed neutralizing antibodies to epoetin alfa
  • No other disorder that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy

  • More than 30 days since prior darbepoetin alfa or epoetin alfa
  • No other concurrent epoetin alfas

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other


Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095,  United States

Study chairs or principal investigators

John A. Glaspy, MD, MPH,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000333213; UCLA-0306021; AMGEN-20030125
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070382
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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